Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan
Background: There were an estimated 7 million people living with diabetes in Pakistan in 2014, and this is predicted to reach 11.4 million by 2030. Aim: To assess if an integrated care package can achieve better control of diabetes. Design & setting: The pragmatic cluster randomised controlled t...
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Format: | Article |
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Royal College of General Practitioners
2018-12-01
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Series: | BJGP Open |
Online Access: | https://bjgpopen.org/content/2/4/bjgpopen18X101618 |
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author | Muhammad Amir Khan John D Walley Nida Khan Joseph Hicks Maqsood Ahmed Shaheer Ellahi Khan Muhammad Ahmar Khan Haroon Jehangir Khan Anthony D Harries |
author_facet | Muhammad Amir Khan John D Walley Nida Khan Joseph Hicks Maqsood Ahmed Shaheer Ellahi Khan Muhammad Ahmar Khan Haroon Jehangir Khan Anthony D Harries |
author_sort | Muhammad Amir Khan |
collection | DOAJ |
description | Background: There were an estimated 7 million people living with diabetes in Pakistan in 2014, and this is predicted to reach 11.4 million by 2030. Aim: To assess if an integrated care package can achieve better control of diabetes. Design & setting: The pragmatic cluster randomised controlled trial (cRCT) was conducted from December 2014–June 2016 at 14 primary healthcare facilities in Sargodha district. Opportunistic screening, diagnostic testing, and patient recording processes were introduced in both the control 'testing, treating, and recording' (TTR) arm, and the intervention 'additional case management' (ACM) arm, which also included a clinical care guide and pictorial flipbook for lifestyle education, associated clinician training, and mobile phone follow-up. Method: Clinics were randomised on a 1:1 basis (sealed envelope lottery method) and 250 patients recruited in the ACM arm and 245 in the TTR-only arm (age ≥25 years and HbA1c >7%). The primary outcome was mean change in HbA1c (%) from baseline to 9-month follow-up. Patients and staff were not blinded. Results: The primary outcome was available for n = 238/250 (95.2%) participants in the ACM arm and n = 219/245 (89.4%) participants in the TTR-only arm (all clusters). Cluster level mean outcome was -2.26 pp (95% confidence intervals [CI] = -2.99 to -1.53) for the ACM arm, and -1.44 pp (95% CI = -2.34 to -0.54) for the TTR-only arm. Cluster level mean ACM–TTR difference (covariate-unadjusted) was -0.82 pp (95% CI = -1.86 to 0.21; P = 0.11). Conclusion: The ACM intervention in public healthcare facilities did not show a statistically significant effect on HbA1c reduction compared to the control (TTR-only) arm. Future evaluation should assess changes after a longer follow-up period, and minimal care enhancement in the comparator (control) arm. |
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id | doaj.art-8182c8d3e48b4161ab80f5f2d2b694c3 |
institution | Directory Open Access Journal |
issn | 2398-3795 |
language | English |
last_indexed | 2024-04-13T14:21:51Z |
publishDate | 2018-12-01 |
publisher | Royal College of General Practitioners |
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series | BJGP Open |
spelling | doaj.art-8182c8d3e48b4161ab80f5f2d2b694c32022-12-22T02:43:25ZengRoyal College of General PractitionersBJGP Open2398-37952018-12-012410.3399/bjgpopen18X101618Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in PakistanMuhammad Amir Khan0John D Walley1Nida Khan2Joseph Hicks3Maqsood Ahmed4Shaheer Ellahi Khan5Muhammad Ahmar Khan6Haroon Jehangir Khan7Anthony D Harries8Association for Social Development, Islamabad, PakistanNuffield Centre for International Health and Development, Leeds Institute of Health Sciences, Leeds, UKAssociation for Social Development, Islamabad, PakistanNuffield Centre for International Health and Development, Leeds Institute of Health Sciences, Leeds, UKAssociation for Social Development, Islamabad, PakistanHumanities and Social Sciences Department, Bahria University, Islamabad, PakistanAssociation for Social Development, Islamabad, PakistanDirectorate General of Health Services, Lahore, PakistanDepartment of Research, International Union Against Tuberculosis and Lung Disease, Winchester, UKBackground: There were an estimated 7 million people living with diabetes in Pakistan in 2014, and this is predicted to reach 11.4 million by 2030. Aim: To assess if an integrated care package can achieve better control of diabetes. Design & setting: The pragmatic cluster randomised controlled trial (cRCT) was conducted from December 2014–June 2016 at 14 primary healthcare facilities in Sargodha district. Opportunistic screening, diagnostic testing, and patient recording processes were introduced in both the control 'testing, treating, and recording' (TTR) arm, and the intervention 'additional case management' (ACM) arm, which also included a clinical care guide and pictorial flipbook for lifestyle education, associated clinician training, and mobile phone follow-up. Method: Clinics were randomised on a 1:1 basis (sealed envelope lottery method) and 250 patients recruited in the ACM arm and 245 in the TTR-only arm (age ≥25 years and HbA1c >7%). The primary outcome was mean change in HbA1c (%) from baseline to 9-month follow-up. Patients and staff were not blinded. Results: The primary outcome was available for n = 238/250 (95.2%) participants in the ACM arm and n = 219/245 (89.4%) participants in the TTR-only arm (all clusters). Cluster level mean outcome was -2.26 pp (95% confidence intervals [CI] = -2.99 to -1.53) for the ACM arm, and -1.44 pp (95% CI = -2.34 to -0.54) for the TTR-only arm. Cluster level mean ACM–TTR difference (covariate-unadjusted) was -0.82 pp (95% CI = -1.86 to 0.21; P = 0.11). Conclusion: The ACM intervention in public healthcare facilities did not show a statistically significant effect on HbA1c reduction compared to the control (TTR-only) arm. Future evaluation should assess changes after a longer follow-up period, and minimal care enhancement in the comparator (control) arm.https://bjgpopen.org/content/2/4/bjgpopen18X101618 |
spellingShingle | Muhammad Amir Khan John D Walley Nida Khan Joseph Hicks Maqsood Ahmed Shaheer Ellahi Khan Muhammad Ahmar Khan Haroon Jehangir Khan Anthony D Harries Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan BJGP Open |
title | Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan |
title_full | Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan |
title_fullStr | Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan |
title_full_unstemmed | Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan |
title_short | Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan |
title_sort | effectiveness of an integrated diabetes care package at primary healthcare facilities a cluster randomised trial in pakistan |
url | https://bjgpopen.org/content/2/4/bjgpopen18X101618 |
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